Transluminal angioplasty devices and methods of use

ABSTRACT

A percutaneous transluminal angioplasty device includes a catheter defining one or more lumens. A filter is coupled to the catheter adjacent a distal end of the catheter, and the filter is movable between an unexpanded and expanded configuration via a filter activation wire that extends through a lumen. An expandable balloon is coupled to the catheter proximally of the filter, and a stent is disposed over at least a portion of the balloon. To deploy the stent to a target site, the filter is first moved into its expanded position via the filter activation wire. Then, the stent is expanded, and the balloon is inflated to expand the stent further radially. The balloon is then deflated, the filter is contracted, and the catheter, balloon, and filter are removed from the body.

CROSS REFERENCE TO RELATED APPLICATION

This application claims priority to U.S. Provisional Patent ApplicationNo. 62/246,839, entitled “Transluminal Angioplasty Device and LayeredStent,” filed Oct. 27, 2015, the content of which is herein incorporatedby reference in its entirety.

BACKGROUND

Angioplasty catheters and stents are used in catheter-based proceduresto open up a blocked vessel and restore blood flow. In general,physicians use separate devices to perform a single procedure. That is,when treating a vascular stenosis, separate devices/tools are used forembolic protection, stent deployment and post-dilation of the stent. Theuse of multiple devices to complete a single procedure has manydrawbacks. For example, exchanging devices leads to longer proceduretime, which poses patient safety risks; manipulation of multiple devicesposes potential clinical risk; and interaction between multiple devicesposes a risk of device failure. Thus, it is necessary for the surgeon tobe trained on multiple devices, and there are higher costs to usemultiple devices separately.

More specifically, when treating vascular lesions within the carotidarteries, there is a known risk of embolic material being liberated fromthe site of treatment during stent deployment or post-deployment balloondilation of the stent. These embolic particles increase the risk ofstroke. To address this risk, many types of vascular embolic filtershave been designed. These filters are positioned within the artery pastthe lesion to be treated and remain in place during the entireprocedure. To ensure adequate flow of blood during this time, the filterneed to have large pores (100 microns or greater) and are thus onlycapable of capturing the biggest embolic particles. However, clinicalresearch has shown that smaller diameter embolic particles can alsocause stroke. Filter designed to capture small particles can only beleft open for a short period. Thus, there is a need for a system thatcombines multiple products (embolic filter, stent and angioplastyballoon) into a single system that also allows for an embolic filterwith small diameter pores (40 microns) to be used ensuring greatercapture of embolic material.

In addition, stents are frequently used in conjunction with angioplastydevices in the treatment of vascular narrowing. Carotid stents, as wellas stents used in other arterial and venous applications, need toprovide sufficient radial strength to keep calcified lesions open andprovide sufficient flexibility to travel through and conform to tortuousvessels. In addition, a low area between stent struts is needed toprevent plaque from embolizing through the stent and into the distalvasculature.

Accordingly, a need in the art exists for a treatment device thatcombines multiple tools needed to treat vascular stenosis into a singledevice.

SUMMARY

Various implementations include a percutaneous transluminal angioplastydevice that includes a multi-lumen catheter, a filter, an expandableballoon, and a stent. The multi-lumen catheter has a proximal end and adistal end. The catheter defines a first lumen, a second lumen, and athird lumen, and each lumen extends through at least a portion of thecatheter. The filter is disposed adjacent the distal end of thecatheter, and the filter is movable between unexpanded and expandedconfiguration. The expandable balloon is disposed between the filter andthe distal end of the catheter. The stent extends over at least aportion of the expandable balloon. In some implementations, the devicealso includes a movable sheath that extends over at least a portion ofthe stent, and a sheath wire is coupled to the movable sheath. Thesheath wire extends through one of the lumens defined by the catheter,and movement of the sheath wire translates the sheath axially.

In some implementations, the stent is a self-expanding stent, and theself-expanding stent is constrained in place over at least a portion ofthe balloon by the movable sheath and expands in response to the movablesheath being moved axially away from the self-expanding stent. In someimplementations, the sheath wire is moved axially to translate thesheath axially, and the axial movement of the sheath wire translates thesheath in the same direction as the axial movement of the sheath wire.

In some implementations, the device further includes a filter activationwire that is disposed within a first lumen, and a distal end of thefilter activation wire is coupled to the filter.

In some implementations, the filter includes a filter frame and a filtermembrane. The filter frame has a distal end and a proximal end, and theproximal end of the filter frame is fixedly coupled to the catheter. Thedistal end of the filter frame is slidably coupled to the catheter. Thefilter membrane has a distal end and proximal end, and the distal end ofthe filter membrane is fixedly coupled to the catheter distally of theproximal end of the filter membrane and the distal end of the filterframe. The proximal end of the filter membrane is fixedly coupled to aportion of the filter frame. The distal end of the filter activationwire is coupled to the distal end of the filter frame, and tensioningthe filter activation wire in a proximal direction urges the distal endof the filter frame in axial proximal direction from an unexpandedconfiguration to an expanded configuration.

In some implementations, the device includes a handle coupled to aproximal end of the catheter, and the handle is coupled to the filteractivation wire and the sheath wire. For example, in someimplementations, the handle includes a first actuator coupled to thefilter activation wire and a second actuator coupled to the sheath wire.The first actuator is manipulatable to expand and contract the filtervia the filter activation wire, and the second actuator is manipulatableto axially move the sheath.

In some implementations, the third lumen is a balloon inflation lumen,and the catheter further defines an inflation port between an externalsurface of the catheter and the third lumen.

In some implementations, the catheter defines a guidewire port, and theguidewire port has a first opening defined by one of the first, second,or third lumen and a second opening defined by an exterior surface ofthe catheter. The first opening of the guidewire port is disposeddistally relative to the second opening. In a further implementation, aguide wire is disposed within at least a portion of the first, second,or third lumen that defines the first opening of the guidewire port.

In some implementations, at least a portion of the filter has a radiusin the expanded configuration that corresponds to an inner diameter of ablood vessel into which the filter is disposed.

In some implementations, the catheter includes a proximal portion and adistal portion, and the proximal portion is disposed adjacent a proximalend of the catheter and the distal portion is disposed adjacent a distalend of the catheter. The proximal portion of the catheter defines asheath wire lumen, a proximal filter activation wire lumen, and aproximal balloon inflation lumen. The distal portion of the catheterdefines a guidewire lumen, a distal filter activation wire lumen, and adistal balloon inflation lumen. In further implementations, the proximalballoon inflation lumen and the distal balloon inflation lumen areaxially aligned, the proximal filter activation wire lumen and thedistal filter activation wire lumen are axially aligned, and/or thesheath wire lumen and the guidewire lumen are axially aligned.

In some implementations, the stent includes a plurality ofcircumferentially arranged rings that are axially spaced apart, and therings have a sinusoidal pattern around a circumference of each ring.Each ring is coupled to an axially adjacent ring by one or more axiallyelongated struts. For example, in certain implementations, the stent hasa first end, a second end, a central portion, and a longitudinal axisextending between the first and second ends. A diameter of the centralportion is less than a diameter of the first end and a diameter of thesecond end, and a diameter of the stent increases parabolically from thecentral portion toward each end.

In some implementations, the elongated struts are arranged in ans-pattern. The elongated struts in a first row have a first orientation,the elongated struts in a second row adjacent to the first row have asecond orientation, and the first orientation and the second orientationare mirror images of each other.

In some implementations, each elongated strut is coupled between offsetand opposing apexes of the sinusoidal pattern of adjacent ring segmentssuch that the elongated strut extends around a portion of thecircumference of the stent.

In some implementations, the stent comprises a first hollow tubularmember and a second hollow tubular member, the first tubular memberbeing coupled to the second tubular member such that a central portionof the first tubular member is disposed adjacent a central portion ofthe second tubular member. For example, in certain implementations, thefirst hollow tubular member includes a plurality of ring segmentsextending circumferentially around the first tubular member and anelongated strut connecting two adjacent ring segments located at acentral portion of the first tubular member. The second hollow tubularmember includes a second plurality of ring segments extendingcircumferentially round the second tubular member and a second elongatedstrut connecting two adjacent ring segments.

In some implementations, the stent includes first hollow tubular memberand second hollow tubular member. The first tubular member is disposedadjacent an end portion of the second tubular member such that at leasta portion of the first member overlaps a portion of the second member.

In some implementations, the stent is a self-expanding stent, acontrolled/direct expansion stent, or a balloon expandable stent.

Various other implementations include a method of deploying a stent. Themethod includes: (1) routing a percutaneous transluminal angioplastydevice through a body to a site of a vascular stenosis, the deviceincludes a multi-lumen catheter, a filter, a stent, and an expandableballoon; (2) disposing a distal end of the catheter downstream of thevascular stenosis such that the stent is disposed radially inward of thevascular stenosis and the filter is disposed downstream of the vascularstenosis; (3) deploying the filter downstream of the vascular stenosis;(4) deploying the stent after the filter is deployed; (5) inflating theballoon to post-dilatate the stent; (6) deflating the balloon; (7)contracting the filter; and (8) removing the catheter from the body.

In some implementations, the device further includes an axially movablesheath, and the stent is disposed over at least a portion of theexpandable balloon and at least a portion of the stent. And, the methodfurther includes axially moving the sheath proximally to expose thestent and allow the stent to expand into an expanded position.

The details of one or more embodiments of the disclosure are set forthin the accompanying drawings and the description below. Other features,objects, and advantages of the disclosure will be apparent from thedescription and drawings, and from the claims.

BRIEF DESCRIPTION OF DRAWINGS

Various implementations of a stent and a percutaneous transluminalangioplasty device are described in detail in the following drawings.The drawings are merely exemplary to illustrate the structure ofstents/devices and certain features that may be used singularly or incombination with other features. The invention should not be limited tothe examples shown.

FIG. 1 is a side view of an exemplary layered stent according to oneimplementation;

FIG. 2 is a side view of a first hollow tubular member of the stent inFIG. 1;

FIG. 3 is a side view of a second hollow tubular member of the stent inFIG. 1;

FIG. 4 is a side view of an exemplary percutaneous transluminalangioplasty device according to one implementation;

FIG. 5 is a side view of the percutaneous transluminal angioplastydevice shown in FIG. 4 with the filter assembly exposed and unexpanded;

FIG. 6 is a side view of the percutaneous transluminal angioplastydevice shown in FIG. 4 with the filter assembly expanded;

FIGS. 7A-7F is a side view of the percutaneous transluminal angioplastydevice of FIG. 4 with the movable sheath retracted in various positionsto show the expansion of a stent and inflation of the balloon and theoperation of the device to set the stent in the body;

FIG. 8 is a cross sectional view of the percutaneous transluminalangioplasty device as taken through the B-B line of FIG. 4;

FIG. 9 is a cross sectional view of the percutaneous transluminalangioplasty device as taken through the C-C line of FIG. 4;

FIGS. 10A-10C illustrate a side view, partial cross sectional view, andan exploded view, respectively, of a handle according to oneimplementation;

FIG. 11 illustrates a side view of a stent stop disposed on the catheteraccording to one implementation;

FIG. 12 illustrates a side view of portions of the sheath according toone implementation;

FIGS. 13A-13D illustrate a stent according to another implementation;

FIGS. 14A-14C illustrate a stent according to another implementation;

FIGS. 15A-15C illustrate a stent according to another implementation;

FIG. 16 illustrates a cross sectional view of the catheter shown in FIG.4 as taken along the longitudinal axis A-A;

FIG. 17A illustrates a side view of the catheter in FIG. 4 having asleeve, according to one implementation; and

FIG. 17B illustrates a cross sectional view of the catheter and sleevein FIG. 17A as taken through the D-D line.

DETAILED DESCRIPTION

Certain terminology is used in the following description for convenienceonly and is not limiting. The words “right,” “left,” “lower,” and“upper” designate direction in the drawings to which reference is made.The words “inner” and “outer” refer to directions toward and away from,respectively, the geometric center of the described feature or device.The words “distal” and “proximal” refer to directions taken in contextof the item described and, with regard to the instruments hereindescribed, are typically based on the perspective of the surgeon usingsuch instruments. The terminology includes the above-listed words,derivatives thereof, and words of similar import.

Various implementations relate to percutaneous transluminal angioplastydevices and stents suitable for use therewith. FIG. 1 provides a sideview of an exemplary layered stent 100 according to one implementation.The stent 100 includes first and second tubular members 120, 140. In oneimplementation, the first and/or second tubular members 120, 140 areself-expanding. In other implementations, the first and/or secondtubular members 120, 140 are balloon-expandable. As will be described inmore detail below, the first and second tubular members 120, 140 arecoupled together such there is overlap of the two members 120, 140. Forexample, as illustrated in FIG. 1, the second tubular member 140 iscoupled to the first tubular member 120 such that the central portion122 of the first tubular member 120 is disposed adjacent the centralportion 142 of the second tubular member 140. In other implementations(not shown), the second tubular member 140 extends over the firsttubular member 120 at a location other than the central portion 122 ofthe first tubular member 120. For example, the second tubular member 140may extend over a portion of the proximal or distal end 123, 125 of thefirst tubular member 120. Additionally, the second tubular member mayhave a length equal to the first tubular member and may extend over theentirety of the first tubular member 120.

FIG. 2 provides a side view of an exemplary first hollow tubular member120 according to one implementation. The first tubular member 120includes a plurality of ring segments 124 extending circumferentiallyaround the perimeter of the first tubular member 120. At least some ofthe ring segments 124 are connected by an elongated strut 126. Asillustrated in FIG. 2, ring segments 124 disposed adjacent the centralportion 122 of the first tubular member 120 are connected by elongatedstruts 126. The elongated strut 126 provides greater flexibility betweenthose adjacent ring segments 124 than between ring segments withstandard (or non-elongated) struts. For example, the elongated struts126 provided between ring segments 124 disposed adjacent the centralportion 122 of the first tubular member 120 provide for greaterflexibility between ring segments 124 than between those ring segmentdisposed adjacent the proximal end 123 or distal end 125 of the tubularmember 120. As provided in FIG. 2, the central portion 122 of the firsttubular member 120 includes at least four ring segments 124 coupled byelongated struts 126. The proximal and distal end 123, 125 portionsdisposed on opposing sides of the central portion 122 include at leasttwo adjacent ring segments 124. However, in other implementations, thecentral portion 122 and proximal end 123 and distal end 125 include anynumber of ring segments 124. And, in other implementations, the adjacentring segments 124 of the proximal and distal end 123, 125 portions arecoupled by non-elongated struts/connectors 128.

FIG. 3 provides a side view of an exemplary second hollow tubular member140 according to one implementation. Similar to the first tubular member120, the second tubular member 140 includes a plurality of ring segments144 extending circumferentially around a perimeter of the second tubularmember 140. At least some of the ring segments 144 are connected by anelongated strut 146. As illustrated in FIG. 3, each of the ring segments146 of the second tubular member 140 are connected by elongated struts146. Similar to elongated struts 126 described above, the elongatedstrut 146 provides greater flexibility between adjacent ring segments144 than between those ring segments with standard (or non-elongated)struts. As shown, the second tubular member 140 includes at least tworing segments 144. However, in other implementations (not shown), thesecond tubular member 140 includes adjacent ring segments 144 coupled bynon-elongated struts/connectors 148, similar to those ring segmentslocated at the proximal and distal ends 123, 125 of the first tubularmember 120. As illustrated in FIG. 3, the second tubular member 140generally has a shorter length than the first tubular member 120.However, in other implementations, the second tubular member 140 is aslong as, or longer than, the first tubular member 120.

As described above, elongated struts 126, 146 provide greaterflexibility between adjacent ring segments than between those ringsegments with standard (or non-elongated) struts. As provided in FIGS. 2and 3, the elongated struts 126, 146 have a longitudinal length (L)greater than the longitudinal length (I) of an adjacent ring segment. Inother implementations, the elongated struts 126, 146 have a longitudinallength (L) equal to or less than the longitudinal length (I) of anadjacent ring segment. As illustrated in FIGS. 2 and 3, the longitudinallength (L) of the elongated struts 126, 146 on the tubular member isconsistent along the entire length of the tubular member. For example,in the implementation, the first tubular member 120 (or second tubularmember 140) includes a first pair adjacent ring segments 124 separatedby a first set of elongated struts 126 a, a second pair of adjacent ringsegments 124 connected by a second set of elongated struts 126 b, and athird pair of adjacent ring segments 124 connected by a third set ofelongated struts 126 c. FIG. 2 illustrates that the longitudinal lengthof the first, second and third set of elongated struts 126 a, 126 b, 126c is the same. However, in other implementations, the longitudinallength of the elongated struts 126, 146 between various ring segments124, 144 varies along the length of the tubular member.

In some implementations, the elongated struts 126, 146 of the first andsecond tubular members 120, 140 are made from the same material as thecorresponding ring segments 124, 144. And, in other implementations, theelongated struts 126, 146 are made from a different material as thecorresponding ring segments 124, 144. For example, the ring segments124, 144 and the elongated struts 126, 146 of the corresponding tubularmember include wires of different metals. In addition, in someimplementations, the elongated struts 126, 146 also have a thicknessdifferent from the thickness of the lattice member/wire of the ringsegments 124, 144 of the corresponding first and second tubular members120, 140. For example, as illustrated in FIGS. 1-3, the elongated struts126, 146 have a thickness less than the thickness of the latticemember/wire of the ring segments 124, 144 of the corresponding first andsecond tubular members 120, 140.

As illustrated in FIGS. 1-3, the ring segments 124, 144 extendcircumferentially around the perimeter of each tubular member 120, 140.For example, in some implementations, the ring segments 124, 144 extendcircumferentially around the tubular members in an undulating pattern.In another implementations, the ring segments 124, 144 extend around thetubular member in a zig-zag or sinusoidal pattern. As illustrated inFIGS. 2 and 3, the elongated struts 126, 146 extend around a portion ofthe circumference of the tubular member. For example, the individualelongated struts 126, 146 extend between offset and opposing apexes ofthe undulating pattern of adjacent ring segments.

As outlined above, the first tubular member 120 and the second tubularmember 140 are coupled together such there is overlap of the twomembers. FIG. 1 illustrates the second tubular member 140 disposed overthe first tubular member 120. However, in other implementations, thefirst tubular member 120 is disposed over the second tubular member 140.In the implementation shown in FIG. 1, the second tubular member 140 iscoupled to the first tubular member 120 such that the central portion122 of the first tubular member 120 is disposed adjacent the centralportion 142 of the second tubular member 140. In another implementation(not shown), the second tubular member 140 is coupled to/extends overthe first tubular member 120 at a proximal or distal end 123, 125 of thefirst tubular member 120. As provided in FIG. 1, the first and secondtubular members 120, 140 are layered such that the elongated struts 126,146 of the corresponding tubular members extend around the stent 100 indifferent directions. The layering of the first and second tubularmembers 120, 140 and the overlap of elongated strut sections 126, 146,increases the radial strength of the stent 100, which helps to keepcalcified lesions open, allows the stent 100 to be flexible, which helpsthe stent 100 travel through and conform to tortuous vessels, andreduces the area between stents struts 126, 146/overlapping latticestructure to prevent plaque from embolizing through the stent 100.

According to some implementations, the first and second tubular members120, 140 are slidably coupled together such that the first and secondtubular members 120, 140 are moveable in both longitudinal androtational directions with respect to the other. For example, thetubular members are connected at corresponding connectors 128, 148disposed on the first and second tubular members 120, 140, respectively.As illustrated in FIGS. 2 and 3, the connectors 128, 148 extend axiallyfrom a ring segment 124, 144 of the first and second tubular members120, 140. The connectors 128, 148 are disposed between opposing apexesof adjacent ring segments. In other implementations, each of the firstand second tubular members 120, 140 include a plurality of connectors128, 148. The connectors 128, 148 include an opening that receives acoupling member (not shown). The coupling member extends through arespective opening to fix the two connectors together. An exemplarycoupling member includes a radio-opaque marker. In otherimplementations, the first and second tubular members 120, 140 arecoupled to/fixed together to prevent relative movement between members120, 140.

According to various implementations, the first and second tubularmembers 120, 140 include a wire, a sheet metal, or tube. The ringsegments 124, 144 and elongated struts 126, 146 of the first and secondtubular members 120, 140 define lattice structures/members. For example,the ring segments 124, 144 and/or elongated struts 126, 146 define anopen structure, a closed structure, or braided lattice structure.

In addition, according to various implementations, the first and secondtubular members 120, 140 are formed from a variety of biocompatiblematerials, such as cobalt chromium, titanium and titanium alloys,stainless steel, nitinol, platinum, gold, or other metals, as well asceramics or polymers. In addition, the first and second tubular members120, 140 include a coated or sheathed material. For example, the firstand second tubular members 120, 140 include a bioresorbable material orhave a bioresorbable coating or sheathing.

FIGS. 13A-13D illustrate a stent 400 according to anotherimplementation. The stent 400 is a single layer stent that has anhourglass shape when deployed, as viewed from the side as shown in FIG.13A. In particular, a diameter of the stent 400 varies along alongitudinal axis A′-A′ extending through the stent 400. A mid portion403 of the stent 400 has a diameter that corresponds to a diameter ofthe vessel in which the stent 400 is being deployed, and the diameter ofthe stent 400 increases parabolically along the longitudinal axis A′-A′from the mid portion 403 to each flared end 402, 404, forming thehourglass shape. In some implementations, the diameter at end 402 is thesame as the diameter at end 404, and in other implementations, thediameter at one end 402, 404 is larger than the diameter at the otherend 404, 402. In some implementations, the diameter at the mid portion403 is half of the diameter at the flared ends 402, 404. The hourglassshape of the stent 400 and the flared ends 402, 404 allow for betterapposition to the vessel wall, especially in tortuous vessel anatomy.

In addition, the stent 400 has a plurality of ring segments 403 having asinusoidal pattern extending around the circumference of the stent 280.Elongated struts 407 having a z-shape extend between axially adjacentrings 403. The struts 407 are coupled to a portion of each ring 403between adjacent apexes 405, 406. Each strut 407 has a bend at a centralportion 408 thereof that extends circumferentially from the ends 409,411 thereof. In the implementation shown in FIGS. 13A-13D, the stent 400has thirteen rings and twelve rows of elongated struts coupling adjacentrings.

FIGS. 14A-14C illustrate a stent 500 according to anotherimplementation. Like stent 400, stent 500 is also a single layer stenthaving an hourglass shaped when deployed, but the elongated struts 507are arranged differently than with stent 400. In particular, theelongated struts 507 of stent 500 extend between axially adjacent apexeson a first ring to between adjacent apexes on a second, adjacent ring,but the central portion 508 of the strut 507 is disposed between a rightfacing apex 405 of one ring and a left facing apex 406 of an adjacentring. The strut 507 forms an s-shape, and the struts 507 in each rowhave the same orientation.

FIGS. 15A-15C illustrate a stent 600 according to anotherimplementation. Stent 600 is similar to stent 500 except that theelongated struts 607 a, 607 b between the rings have alternatingorientations. In particular, the orientation of the struts 607 a betweena first ring and a second ring are in one direction, and the orientationof the struts 607 b between the second ring and a third ring are in theopposite, or mirror image, direction.

FIGS. 4-9 provide various views of an exemplary percutaneoustransluminal angioplasty device 200 according to one implementation. Thestents 100, 400, 500, 600 described above in relation to FIGS. 1-3 and13A-15C or any other suitable stent structure known in the art is usablewith the angioplasty device 200. According to the implementation shownin FIGS. 4-9, the angioplasty device 200 includes a catheter 220 havingone or more axial lumens extending at least partially through thecatheter, an integrated filter assembly 240, an expandable balloon 260,a stent 280, and an axially movable sheath 284.

FIG. 4 is a side view of the percutaneous transluminal angioplastydevice 200 with the sheath 284 covering the filter assembly 240, stent280, and balloon 260. FIGS. 5-7F illustrate the configuration andoperation of the device 200 as the filter assembly 240 and stent 280 aredeployed and the filter assembly 240 is then collapsed and removed withthe device 200, leaving the stent 280 in place within the body.

In the implementation shown in FIGS. 4 and 16, the device 200 includes acatheter 220 having a proximal end 225 and a distal end 223. Thecatheter 220 has a proximal portion 220 a that is disposed adjacent theproximal end 225 and a distal portion 220 b that is disposed adjacentthe distal end 223. The proximal portion 220 a and the distal portion220 b are coupled together at mid portion 220 c. For example, theproximal portion 220 a and the distal portion 220 b are integrallyformed together at mid portion 220 c according to some implementations.And, in other implementations, the portions 220 a, 220 b are formedseparately and coupled together at mid portion 220 c using thermal orchemical bonding mechanisms, for example. In other implementations, thecatheter 220 includes one or more portions, and the number of portionsdepends at least in part on the control components to be provided by thedevice.

FIG. 8 illustrates a cross sectional view of the proximal portion 220 aof the catheter 220 as taken through line B-B as shown in FIG. 4, andFIG. 9 illustrates a cross sectional view of the distal portion 220 b ofthe catheter 220 as taken through line C-C as shown in FIG. 4, accordingto one implementation. The cross sectional views in FIGS. 8 and 9illustrate an exemplary arrangement of one or more lumens extendingthrough at least a portion of the catheter 220. As shown in FIG. 8, theproximal portion 220 a defines a proximal balloon inflation lumen 224 a,a sheath wire lumen 226, and a proximal filter activation wire lumen 222a. And, as shown in FIG. 9, the distal portion 220 b defines a distalballoon inflation lumen 224 b, a distal filter activation wire lumen 222b, and a guidewire lumen 227. In some implementations, the proximal anddistal balloon inflation lumens 224 a, 224 b are axially aligned, and inother implementations, the lumens 224 a, 224 b are in communication witheach other but are not axially aligned. Similarly, in someimplementations, the proximal and distal filter activation wire lumens222 a, 222 b are axially aligned, and in other implementations, thelumens 222 a, 222 b are in communication with each other but are notaxially aligned. And, in some implementations, the sheath wire lumen 226is axially aligned with the guidewire lumen 227, and otherimplementations, the sheath wire lumen 226 and the guidewire lumen 227are not axially aligned. Further, in some implementations, the sheathwire lumen 226 and the guidewire lumen 227 are in communication witheach other, regardless of their axial alignment. In addition, in someimplementations, distal ends of one or more of lumens 222 a, 224 a, 226in the proximal portion 220 a of the catheter 220 are axially spacedapart from proximal ends of one or more lumens 222 b, 224 b, 227 in thedistal portion 220 b of the catheter 220. And, in some implementations,the distal ends of one or more lumens 222 a, 224 a, 226 abut theproximal ends of one or more lumens 222 b, 224 b, 227 in the distalportion 220 b of the catheter 220.

According to various implementations, the lumens are sized toaccommodate various control components passing through the lumens, andthe orientation, sizes, and/or number of lumens shown in FIGS. 8 and 9is selected depending on the components to be controlled by the device200. In addition, the control components described above in relation toFIGS. 4-9 are exemplary, and, in other implementations, the deviceincludes more or less control components and/or lumens, depending on theintended use of the device. Furthermore, the lumens described above inrelation to FIGS. 4-9 receive one control component each, but in otherimplementations, one or more lumens are sized to receive one or morecontrol components.

As illustrated in FIGS. 4-7F, the device 200 further includes a distaltip 235 coupled to the distal end 223. In the implementation shown inFIGS. 4-7F, the distal tip 235 is conical or frusto-conically shaped tofacilitate penetration through the body. The tip 235 defines a guidewireport through which a guidewire 250 extends during placement of thedevice 200 within the body. The tip 235 according to one implementationincludes a low durometer material, such as PEBAX. However, in otherimplementations, the tip includes other suitable shapes (e.g., sphericalor hemispherical, pyramidal, blunted) depending on the intended path ofthe tip through the body.

According to the implementation shown in FIGS. 4-7F, the filter assembly240 is coupled to the distal portion 220 b of the catheter 220 adjacentthe distal end 223 of the catheter 220 and is disposed axially proximalto the tip 235. The filter assembly 240 is moveable between an expandedand unexpanded configuration. The filter assembly 240 in the unexpandedconfiguration, which is illustrated in FIGS. 5 and 7E, is sized andconfigured for insertion and passage through a blood vessel. In theexpanded configuration, illustrated in FIGS. 6 and 7A-7D, the filterassembly 240 is sized and configured to capture emboli within thebloodstream. For example, at least a portion of the filter assembly 240in the expanded configuration extends across a diameter of the vessel tocatch emboli that may be flowing through the bloodstream.

The filter assembly 240 includes a filter membrane 240 a and a filterframe 240 b. The filter membrane 240 a is frusto-conically shape, andthe filter frame 240 b is egg shaped in the implementations shown inFIGS. 5-7D. A conical tip 240 c of the membrane 240 a is fixedly coupledaround the distal portion 220 b of the catheter 220, and a distal end240 e of the filter frame 240 b is disposed proximally of the conicaltip 240 c of the membrane 240 a and is slidably coupled around thedistal portion 220 b. A proximal portion 240 f of the filter membrane240 a is fixedly coupled to a central portion 240 g of the filter frame240 b, such as via thermal or chemical bonding or another suitablecoupling mechanism. And, a proximal portion 240 d of the filter frame240 b is fixedly coupled around the distal portion 220 b. In otherimplementations, the shape of the membrane and/or filter frame may bedifferent than shown in FIGS. 5-7D and may be based at least in part onthe anatomy in which the filter assembly is to be disposed.

A filter activation wire 242 extends through the filter activation wirelumens 222 a, 222 b, and a distal end of the filter activation wire 242extends through a filter activation wire port 255 and is coupled to thedistal end 240 e of the filter frame 240 b. The filter activation wireport 255 is defined by the distal portion 220 b of the catheter 220. Thefilter activation wire port 255 has a first opening and a secondopening. The first opening is defined by an external surface of thedistal portion 220 b of the catheter 220 and is disposed between thedistal end 240 e of the filter frame 240 b and the proximal end 240 d ofthe filter frame 240 b. The second opening is defined by lumen 222 b. Insome implementations, the second opening of the port 255 is axiallyproximal the first opening, and in other implementations, the first andsecond openings of port 255 are radially aligned. The filter activationwire port 255 is distally disposed relative to the expandable balloon260 and stent 280.

Tensioning the filter activation wire 242 in the proximal directioncauses the distal end 240 e of the filter frame 240 b to moveproximally, which causes the filter assembly 240 to move from theunexpanded configuration to the expanded configuration. Similarly,releasing tension on the filter activation wire 242 allows the filterassembly 240 to move into the unexpanded configuration. In the expandedposition, an outer diameter of the filter frame 240 b around the centralportion 240 g and an outer diameter of the proximal portion 240 f of thefilter membrane 240 a correspond to an inner diameter of an artery orvessel to ensure that any embolic material is captured by the filterassembly 240. In addition, the filter membrane 240 a and the filterframe 240 b allow blood/fluid to flow therethrough.

According to some implementations, the filter membrane 240 a comprises abiocompatible, elastic polymer sheet (e.g., polyurethane) that definesan array of openings. In certain implementations, the openings are 40micrometers in diameter, which allows blood to flow through but capturessmall particulates. And, in some implementations, the openings areformed by laser drilling. In addition, in various implementations, thefilter frame 240 b comprises a biocompatible, expandable structure thatdefines a plurality of openings. The openings of the filter frame 240 bare larger than the openings defined by the filter membrane 240 a. Thefilter frame 240 b, according to some implementations, includes amaterial having memory properties, such as a braided nitinol structureor a laser cut nitinol tube structure. Other suitable biocompatiblematerials include titanium and titanium alloys, stainless steel,platinum, gold, or other metals, as well as ceramics or polymers. Insome implementations, the filter frame 240 b has a memory of theunexpanded configuration such that when tension on the filter activationwire 242 is released, the filter frame 240 returns toward its unexpandedconfiguration, capturing any embolic materials that have been capturedwithin the filter assembly 240.

In the implementation shown in FIGS. 4-7F, the expandable balloon 260 isdisposed between the proximal end 240 d of the filter frame 240 b andthe proximal end of the distal portion 220 b of the catheter 220. Airand/or fluid is provided to the balloon 260 for inflation via theballoon inflation lumens 224 a, 224 b defined by the proximal portion220 a and distal portion 220 b of the catheter 220, as shown in FIGS. 8,9, and 16. In some implementations, a tube, such as a hypotube, isdisposed within the balloon inflation lumens 224 a, 224 b for deliveringthe air/fluid to the balloon 260. A distal balloon inflation port (notshown) is defined by the distal portion 220 b of the catheter 220 andextends between the balloon inflation lumen 224 b and a portion of theexternal surface of the distal portion 220 b that is in fluidcommunication with an inside of the balloon 260.

The stent 280 is disposed over at least a portion of the balloon 260.According to some implementations, the stent 280 is a self-expandingstent constrained in place over at least a portion of the balloon 260.For example, the stent 280 includes a stent similar to any of theself-expanding stents 100, 400, 500, 600 described above in relation toFIGS. 1-3 and 13A-15C. In other implementations, the stent 280 is acontrolled/directed expansion stent. For example, in suchimplementations having a controlled/directed expansion stent, a stentdeployment wire is coupled to the stent to direct expansion andcontraction of the stent. A stent deployment wire lumen may also bedefined in at least the proximal portion 220 a through which the stentdeployment wire is disposed. In other implementations, the stent is aballoon-expandable stent. The selection of the type, dimensions, and/orradial strength of the stent is based at least in part on the anatomy inwhich the stent is being deployed.

In the implementation illustrated in FIGS. 4-7F, the stent 280 isconstrained by a movable sheath 284 or another type of restrainingelement. Exemplary sheaths include a wire, coiled wire, polymerfilament, or polymer braid sheath. For example, in some implementations,the sheath 280 comprises an inner polymer layer (e.g., PTFE composite)to reduce friction with components disposed radially within the sheath280, a structural sheath layer (e.g., a wire, coiled wire, polymerfilament, or polymer braid sheath layer (e.g., a braided stainless steelsheath layer)) to maintain the radial strength of the sheath 280, and anouter polymer layer (e.g., nylon) to protect the structural sheathlayer. In addition, the sheath 280 is a 6F sheath/8F guide compatiblesheath, according to one implementation. The movable sheath 284 extendsover the stent 280 and filter assembly 240 in the implementation shownin FIG. 4. However, in some implementations, the sheath 284 does notextend over the filter assembly 240, and in other implementations, thesheath 284 extends over a portion of the filter assembly 240.

Furthermore, in the implementation shown in FIG. 12, the sheath 284includes a radio-opaque marker 293 around a portion of the sheath 284 toassist in locating the stent 280 within the body prior to stentdeployment. However, in other implementations, the sheath 284 may notinclude the radio-opaque marker 293. In addition, in someimplementations, the sheath 284 may be tapered from its distal endtoward its proximal end, wherein the distal end of the sheath 284 has alarger diameter than the proximal end of the sheath 284.

As shown in FIG. 16, a sheath wire exit port 288 is defined between anexternal surface of the proximal portion 220 a of the catheter 220 andthe sheath wire lumen 226, and a sheath wire 286 extends between thesheath wire lumen 226 and the sheath 284 via the sheath wire exit port288. In one implementation, the sheath wire exit port 288 is definedadjacent a distal end of the proximal portion 220 a of the catheter 220.A distal end of the sheath wire 286 is coupled to the sheath 284. Insome implementations, the sheath wire 286 is coupled to the sheath 284by embedding the distal end of the sheath wire 286 between the braidedstructural layer and the outer polymer layer.

By disposing the sheath wire 286 within the proximal portion 220 a ofthe catheter 220, the physician is able to stabilize (e.g., hold steady)the catheter 220 while the sheath 284 is moved axially proximal to thestent 280, which reduces or prevents movement of the distal portion 220b of the catheter 220 and unintentional axial movement of the stentrelative to the target location during deployment of the stent (alsoknown as “stent jumping”). In known devices, the sheath is not coupledto a sheath wire, and the sheath extends proximally over the entirelength of the catheter. Thus, there is no space available on thecatheter to hold the catheter steady during sheath deployment. Knowndevices do not include a sheath wire.

In the implementation shown in FIG. 4, a portion of the sheath wire 286extending between the sheath wire lumen 226 and the sheath 284 isexposed. However, in some implementations, such as is shown in FIGS. 12and 17A and 17B, a sleeve 290 (e.g., a polymer sleeve) is disposed atleast partially around the exposed portion of the sheath wire 284 andthe mid portion 220 c of the catheter. At least a portion of theexterior surface of mid portion 220 c defines a recessed, axiallyextending groove 226 b that is in communication with the sheath wirelumen 226 defined by the proximal portion 220 a. The sheath 284 isradially movable in and out of the groove 226 b. In the implementationshown, guidewire 250 is routed through a proximal end of the sleeve 290toward the guidewire lumen 227 defined by the distal portion 220 b ofthe catheter 220. In the implementation shown in FIGS. 12 and 17A, thesheath 284 and the sleeve 290 are coupled together. However, in otherimplementations, the sheath 284 and sleeve 290 are separately formed anddisposed axially adjacent each other.

In the implementation shown in FIGS. 4 and 16, a proximal end of thedistal portion 220 b of the catheter 220 defines a guidewire port 302that extends between the guidewire lumen 227 and an external surface ofthe catheter 220. The opening of the guidewire port 302 defined by theexternal surface of the catheter 220 is proximal to guidewire lumen 227to facilitate rapid exchange of the guidewire 250. In the implementationshown, the guidewire port 302 is defined by the opening of the guidewirelumen 227 at the proximal end of the distal portion 220 b. A proximalportion of the guidewire 250 extends out of the distal portion 220 b ofcatheter 220 proximally of the sheath 284 via the guidewire port 302.The guidewire 250 according to some implementations has a diameter ofbetween 0.010 inches and 0.038 inches (e.g., 0.014 inches). In otherimplementations, the guidewire port includes a first opening and asecond opening. The first opening of the guidewire port is defined bythe exterior surface of the catheter that is radially spaced apart fromthe guidewire lumen 227, and the second opening of the guidewire port isdefined by an interior surface of the lumen 226 and is distally spacedapart from the first opening along the longitudinal axis of theguidewire lumen 227. That is, in various implementations, the guidewireport extends through the catheter 220 from a first opening towards asecond opening defined by a lumen that is distally spaced from the firstopening.

As illustrated in FIG. 11, a deployment stopper 285 is disposedproximally of the stent 280 (e.g., adjacent the proximal end of theballoon 260) to prevent the stent 280 from moving axially during removalof the sheath 284. In some implementations, the stopper 285 is a nylonstop that is adhesively bonded to the distal portion 220 b of thecatheter 220. The stopper 285 ensures that the working length of theballoon 260 is disposed within the length of the stent 280. And, thepositioning of the stent 280 relative to the balloon 260 accounts forshortening of the stent 280 post deployment. In other implementations,the deployment stopper 285 is formed of any suitable material and ismoveably or fixedly coupled to, integrally formed with, or independentof the movable sheath 284 and/or the distal portion 220 b of thecatheter 220.

The control component-lumen designations described herein are onlyexemplary implementations of the disclosed device and are in no waylimiting as the only or preferred implementations. In anotherimplementation (not shown), the catheter includes a fourth lumen thatextends axially through at least a portion of the catheter. For example,in an implementation in which the sheath is removed by a sheath wire andthe stent is expandable by moving a stent deployment wire, the sheathdeployment wire extends through the fourth lumen. However, in someimplementations, the stent deployment wire is disposed within the lumenof the sheath wire.

As shown in FIGS. 10A-10C, the device 200 further includes a handle 290coupled to a proximal end 225 of the proximal portion 220 a of thecatheter 220. In some implementations, the handle 290 includes controls(e.g., buttons, knobs, etc.) that are coupled to one or more of thefilter activation wire 242, the sheath wire 286, and/or the guidewire250 to allow the user to actuate the filter 240, the sheath 284, and/orthe guide wire 250. In the implementation shown in FIGS. 10A-10C, knobs310, 315 are disposed on the handle 290 and are coupled to the filteractivation wire 242 and the sheath wire 286, respectively. Actuation ofthe knobs 310, 315 in one direction causes the respective wires to betensioned proximally, and actuation of the knobs 310, 315 in theopposite direction releases tension on the wires. In addition, as shownin FIG. 10A, the handle 290 defines a proximal balloon inflation port265 that is in fluid communication with the balloon inflation lumens 224a, 224 b and the balloon 260 to provide air/fluid to the balloon 260 forexpansion.

As will be readily appreciated by those of skill in the art, variousimplementations of the percutaneous transluminal angioplasty device 200and its corresponding components are formed from one or morebiocompatible materials, such as cobalt chromium, titanium and titaniumalloys, stainless steel, nitinol, platinum, gold, or other metals, aswell as ceramics or polymers. In addition, in some implementations, thedevice 200 or portions thereof includes a coated or sheathed material.For example, the device 200 includes a bioresorbable material or has abioresorbable coating or sheathing.

In use, the catheter 220 is advanced over guidewire 250 (e.g., underfluoroscopic guidance) to a target location/stenosis site within a bloodvessel. FIGS. 7A-7F illustrate how the device 200 is operated within thebody according to one implementation. First, the sheath 284 is movedaxially toward the proximal end 225 of the device 200 to expose thefilter assembly 240 by pulling the sheath wire 286 proximally to exposethe filter assembly 240. Then, the filter assembly 240 is deployed intothe expanded configuration by tensioning the filter activation wire 242.Deploying the filter assembly 240 prior to deploying the stent 280allows the filter assembly 240 to catch any embolic material that isdislodged during deployment of the stent 280. Next, the sheath 284 ismoved further axially toward the proximal end 225 to expose the stent280. With the sheath 284 disposed proximally of the stent 280, the stent280 expands radially based on the memory properties of the material ofthe stent 280 for implementations that include a self-expanding stent.In other implementations, other types of stents may be deployed once thesheath 284 is moved to expose the stent 280. Next, the balloon 260 isinflated against an inner surface of the stent 280 such that the stent280 is further radially expanded against the vessel wall(post-dilatation expansion). This step of post-dilatation may berepeated to expand the stenosed region of the artery and expand thestent 280 further radially against/toward the vessel wall. For example,the post-dilatation step may be repeated until the vessel is fullydilated. For example, the balloon 260 is inflated (or deflated) viafluid/air provided to (or removed from) a central chamber of the balloon260 via port 265. After the vessel is fully dilated, the balloon 260 isdeflated, tension in the filter activation wire 242 is released, and thefilter membrane 240 a and the filter net 240 b are collapsed byreleasing the filter activation wire 242, which securely capture anyembolic material captured by the filter assembly 240. The blocked vesselis opened and blood flow is restored. The filter assembly 240 is thencontracted by actuating the filter activation wire 242, and the device200, which includes the deflated balloon 260 and the contracted filterassembly 240, are removed from the vessel. The catheter 220 is movedaxially out of the body, which pulls the filter assembly 240 holding anycaptured embolic material and the unexpanded balloon 260 axially throughthe stent 280 and out of the body. Because the filter assembly 240 isable to capture and hold the embolic material upon release of the filteractivation wire 242, it is not necessary to move the sheath 284 distallyover the filter assembly 240 prior to removal of the device 200 from thebody, which reduces the time required for the procedure.

As noted above, when the sheath wire 286 is tensioned to pull the sheath284 away from the stent 280, the proximal portion 220 a and the distalportion 220 b of the catheter 220 on which the stent 280 and balloon 260are able to be steadied by the physician (e.g., by holding the proximalportion 220 a of the catheter) to prevent or reduce movement of theproximal portion 220 a and the distal portion 220 b relative to thesheath 284.

Having one device 200 that allows the user to actuate a filter, anexpandable balloon, and a sheath and/or stent activation wire reducesthe time required to perform a vascular expansion procedure and reducesthe potential for complications resulting from the procedure.

In some implementations, self-expanding stents 280 provide sufficientflexibility to move through tortuous vessels. The inventors havediscovered that dilating a self-expanding stent 280 radially outwardlyafter the self-expansion of the stent 280 by expanding the balloon 260against the inner surface of the stent 280 increases the diameter of thestent 280. Thus, post-dilatating a self-expanding stent with anexpandable balloon after stent deployment is useful for treatingvascular stenosis in the carotid artery and other tortuous vessels.

In other implementations, the stent is a controlled/directed expansionstent, and a stent deployment wire is actuated to deploy thecontrolled/directed expansion stent. And, in other implementations inwhich the stent is a balloon deployable stent, the stent is deployed byinflating the balloon 260 via the fluid/air provided to the centralchamber of the balloon 260.

In addition, the various embodiments disclosed herein are adaptable foruse in virtually any vessel where the capture emboli within thebloodstream is required for a therapeutic or diagnostic purpose. Inaddition, it is also anticipated that certain embodiments could be usedfor purposes other than medical, such as construction, manufacturing,and excavation, among others; accordingly, nothing herein is intended tolimit application of the various embodiments to purely medical uses.

Accordingly, the subject matter described above is provided by way ofillustration only and should not be construed as limiting. It will beappreciated by those skilled in the art that changes could be made tothe embodiments described above without departing from the broadinventive concept thereof. It is understood, therefore, that thisinvention is not limited to the particular embodiments disclosed, but itis intended to cover modifications within the spirit and scope of thepresent invention, as defined by the following claims.

1. A percutaneous transluminal angioplasty device, comprising: amulti-lumen catheter having a proximal end and a distal end, thecatheter defining a first lumen, a second lumen, and a third lumen, eachlumen extending through at least a portion of the catheter; a filterdisposed adjacent the distal end of the catheter, the filter beingmovable between unexpanded and expanded configuration; an expandableballoon disposed between the filter and the distal end of the catheter;and a stent extending over at least a portion of the expandable balloon.2. The percutaneous transluminal angioplasty device of claim 1, furthercomprising: a movable sheath extending over at least a portion of thestent; and a sheath wire coupled to the movable sheath, the sheath wireextending through one of the lumens defined by the catheter, whereinmovement of the sheath wire translates the sheath axially.
 3. Thepercutaneous transluminal angioplasty device of claim 2, wherein thestent is a self-expanding stent, and the self-expanding stent isconstrained in place over at least a portion of the balloon by themovable sheath and expands in response to the movable sheath being movedaxially away from the self-expanding stent.
 4. The percutaneoustransluminal angioplasty device of claim 2, wherein the sheath wire ismoved axially to translate the sheath axially, and wherein the axialmovement of the sheath wire translates the sheath in the same directionas the axial movement of the sheath wire.
 5. The percutaneoustransluminal angioplasty device of claim 2, wherein a filter activationwire is disposed within a first lumen, and a distal end of the filteractivation wire is coupled to the filter.
 6. The percutaneoustransluminal angioplasty device of claim 5, wherein: the filtercomprises a filter frame and a filter membrane, the filter frame has adistal end and a proximal end, the proximal end of the filter framebeing fixedly coupled to the catheter, and the distal end of the filterframe being slidably coupled to the catheter, the filter membrane has adistal end and proximal end, and the distal end of the filter membraneis fixedly coupled to the catheter distally of the proximal end of thefilter membrane and the distal end of the filter frame, and the proximalend of the filter membrane is fixedly coupled to a portion of the filterframe, and the distal end of the filter activation wire is coupled tothe distal end of the filter frame, wherein tensioning the filteractivation wire in a proximal direction urges the distal end of thefilter frame in axial proximal direction from an unexpandedconfiguration to an expanded configuration.
 7. The percutaneoustransluminal angioplasty device of claim 5, further comprising a handlecoupled to a proximal end of the catheter, the handle coupled to thefilter activation wire and the sheath wire.
 8. The percutaneoustransluminal angioplasty device of claim 7, wherein the handle includesa first actuator coupled to the filter activation wire and a secondactuator coupled to the sheath wire, and the first actuator beingmanipulatable to expand and contract the filter via the filteractivation wire, and the second actuator being manipulatable to axiallymove the sheath.
 9. The percutaneous transluminal angioplasty device ofclaim 1, wherein the third lumen is a balloon inflation lumen, thecatheter further defining an inflation port between an external surfaceof the catheter and the third lumen.
 10. The percutaneous transluminalangioplasty device of claim 1, wherein the catheter defines a guidewireport, the guidewire port having a first opening defined by one of thefirst, second, or third lumen and a second opening defined by anexterior surface of the catheter, wherein the first opening of theguidewire port is disposed distally relative to the second opening. 11.The percutaneous transluminal angioplasty device of claim 10, wherein aguide wire is disposed within at least a portion of the first, second,or third lumen that defines the first opening of the guidewire port. 12.The percutaneous transluminal angioplasty device of claim 1, wherein atleast a portion of the filter has a radius in the expanded configurationthat corresponds to an inner diameter of a blood vessel into which thefilter is disposed.
 13. The percutaneous transluminal angioplasty deviceof claim 1, wherein the catheter comprises a proximal portion and adistal portion, the proximal portion being disposed adjacent a proximalend of the catheter and the distal portion being disposed adjacent adistal end of the catheter, wherein the proximal portion of the catheterdefines a sheath wire lumen, a proximal filter activation wire lumen,and a proximal balloon inflation lumen, and the distal portion of thecatheter defines a guidewire lumen, a distal filter activation wirelumen, and a distal balloon inflation lumen.
 14. The percutaneoustransluminal angioplasty device of claim 13, wherein the proximalballoon inflation lumen and the distal balloon inflation lumen areaxially aligned.
 15. The percutaneous transluminal angioplasty device ofclaim 13, wherein the proximal filter activation wire lumen and thedistal filter activation wire lumen are axially aligned.
 16. Thepercutaneous transluminal angioplasty device of claim 13, wherein thesheath wire lumen and the guidewire lumen are axially aligned.
 17. Thepercutaneous transluminal angioplasty device of claim 1, wherein thestent comprises a plurality of circumferentially arranged rings that areaxially spaced apart, the rings having a sinusoidal pattern around acircumference of each ring, and each ring being coupled to an axiallyadjacent ring by one or more axially elongated struts.
 18. Thepercutaneous transluminal angioplasty device of claim 17, wherein: thestent has a first end, a second end, a central portion, and alongitudinal axis extending between the first and second ends, adiameter of the central portion is less than a diameter of the first endand a diameter of the second end, and a diameter of the stent increasesparabolically from the central portion toward each end.
 19. Thepercutaneous transluminal angioplasty device of claim 17, wherein theelongated struts are arranged in an s-pattern, and the elongated strutsin a first row have a first orientation, the elongated struts in asecond row adjacent to the first row have a second orientation, and thefirst orientation and the second orientation are mirror images of eachother.
 20. The percutaneous transluminal angioplasty device of claim 17,wherein each elongated strut is coupled between offset and opposingapexes of the sinusoidal pattern of adjacent ring segments such that theelongated strut extends around a portion of the circumference of thestent.
 21. (canceled)
 22. (canceled)
 23. (canceled)
 24. The percutaneoustransluminal angioplasty device of claim 1, wherein the stent is aself-expanding stent.
 25. The percutaneous transluminal angioplastydevice of claim 1, wherein the stent is a controlled/direct expansionstent.
 26. The percutaneous transluminal angioplasty device of claim 1,wherein the stent is a balloon expandable stent.
 27. A method ofdeploying a stent comprising: routing a percutaneous transluminalangioplasty device through a body to a site of a vascular stenosis, thedevice comprising a multi-lumen catheter, a filter, a stent, and anexpandable balloon; disposing a distal end of the catheter downstream ofthe vascular stenosis such that the stent is disposed radially inward ofthe vascular stenosis and the filter is disposed downstream of thevascular stenosis; deploying the filter downstream of the vascularstenosis; deploying the stent after the filter is deployed; inflatingthe balloon to post-dilatate the stent; deflating the balloon;contracting the filter; and removing the catheter from the body.
 28. Themethod of claim 27, wherein the device further comprises an axiallymovable sheath, the stent being disposed over at least a portion of theexpandable balloon and at least a portion of the stent, the methodfurther comprising axially moving the sheath proximally to expose thestent and allow the stent to expand into an expanded position.